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Trial record 1 of 1 for:    03845075
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48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)

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ClinicalTrials.gov Identifier: NCT03845075
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Saniona

Brief Summary:

Double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period.

• The study will have two parts:

  • Part 1: 24 weeks double-blind treatment, followed by
  • Part 2: 24 weeks open-label extension - all subjects still participating at the end of Part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the Investigator

Condition or disease Intervention/treatment Phase
Hypothalamic Injury-induced Obesity (HIO) Drug: Tesofensine Drug: Placebo Phase 2

Detailed Description:

Part 1 - the double-blind part: The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks. The placebo arm will receive matching placebo tablets.

Part 2 - the open-label extension part: All active participants at the end of the double-blind part will be given the active medication 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week Phase 2, Double-blind, Randomized, Placebo- Controlled, Single-center Safety and Efficacy Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO), and With a 24-week Open-label Extension, in Total 48 Weeks
Actual Study Start Date : February 20, 2019
Actual Primary Completion Date : October 16, 2020
Actual Study Completion Date : October 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: active arm
The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.
Drug: Tesofensine
During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication)

Placebo Comparator: placebo arm
The placebo arm will receive matching placebo tablets.
Drug: Placebo
During Part 1 subjects will be randomized to matching placebo treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol




Primary Outcome Measures :
  1. Frequency of treatment emergent adverse events [ Time Frame: from Baseline to week 24 ]
    Number and percentage of adverse events in each of the two treatment arms

  2. Severity of treatment emergent adverse events [ Time Frame: from Baseline to week 24 ]
    Number and percentage of mild, moderate and severe adverse events in each of the two treatment arms

  3. Frequency and type of serious adverse events [ Time Frame: from Baseline to week 24 ]
    Number, percentage and type of serious adverse events in each of the two treatment arms

  4. Safety as assessed by systolic blood pressure [mmHg] [ Time Frame: from Baseline to week 24 ]
    Systolic blood pressure in mmHg measured at each visit in each of the two treatment arms

  5. Safety as assessed by diastolic blood pressure [mmHg] [ Time Frame: from Baseline to week 24 ]
    Diastolic blood pressure in mmHg measured at each visit in each of the two treatment arms

  6. Safety as assessed by heart rate [b/min] [ Time Frame: from Baseline to week 24 ]
    Heart rate measured in bpm at each visit in each of the two treatment arms

  7. Safety as assessed by hematology parameters [ Time Frame: from Baseline to week 24 ]
    Number and percentage of deviations from normal range for hemoglobin, platelet counts, white cells count, differential counts at baseline, week 14 and week 24 in each of the two treatment arms

  8. Safety as assessed by electrolytes and creatinine [ Time Frame: from Baseline to week 24 ]
    Number and percentage of deviations from normal range for sodium, potassium, creatinine at each visit in each of the two treatment arms

  9. Safety as assessed by liver and kidney function tests [ Time Frame: from Baseline to week 24 ]
    Number and percentage of deviations from normal range for gamma glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, glomerular filtration rate and urea at baseline, week 14 and week 24 in each of the two treatment arms


Secondary Outcome Measures :
  1. Composite satiety score (CSS) [ Time Frame: from baseline to week 48 ]

    Change in satiety and appetite using the CSS from Baseline to week 24, from Baseline to week 48 and from week 24 to week 48 measured at each visit for each of the two treatment arms

    Full name of the scale: composite satiety score (CSS), sometimes referred to as "appetite suppression score". Range of values is 0-100; lower the value, hungrier a person is. CSS = (satiety + fullness + [100 - hunger] + [100 - prospective food consumption]) / 4. The four variables included are measured by visual analog scales (0-100 mm)


  2. Body weight [ Time Frame: from baseline to week 48 ]
    Change in body weight from baseline to week 24, from baseline to 48 and from week 24 to week 48 measured at each visit for each of the two treatment arms

  3. Body composition - fat mass [ Time Frame: from baseline to week 48 ]
    Change in body fat mass as measured in kg by DXA scan measured at baseline, week 24 and week 48 for each of the two treatment arms

  4. Body composition - lean body mass [ Time Frame: from baseline to week 24, from baseline to week 48 and from week 24 to week 48 ]
    Change in lean body mass as measured in kg by DXA scan measured at baseline, week 24 and week 48 for each of the two treatment arms

  5. Glycemic control - HbA1c [ Time Frame: from baseline to week 48 ]
    Change in HbA1c from baseline to week 24, baseline to week 48 and week 24 to week 48 measured at baseline, week 14, week 24, week 36 and week 48 for each of the two treatment arms

  6. Glycemic control - Fasting Plasma Glucose [ Time Frame: from baseline to week 48 ]
    Change in fasting plasma glucose from baseline to week 24, baseline to week 48 and week 24 to wee 48 measured at each visit for each of the two treatments arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities
  • Males and females, aged 18-75
  • Confirmed diagnosis of HIO
  • BMI ≥27 kg/m2 (where overweight is related to the HIO)

Exclusion Criteria:

  • BP ≥160/90 mmHg
  • HR ≥ 90, <50 bpm
  • Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or Prader-Willi syndrome
  • Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure
  • Previous myocardial infarction or stroke within the last 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845075


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 210
Sponsors and Collaborators
Saniona
Investigators
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Principal Investigator: Ulla Feldt-Rasmussen, MD, DMSc Department of Medical Endocrinology and metabolism Rigshospitalet,Copenhagen, DK
  Study Documents (Full-Text)

Documents provided by Saniona:
Study Protocol  [PDF] December 10, 2019
Statistical Analysis Plan  [PDF] May 17, 2019

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Responsible Party: Saniona
ClinicalTrials.gov Identifier: NCT03845075    
Other Study ID Numbers: TM005
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Wounds and Injuries
Overnutrition
Nutrition Disorders
Overweight
Body Weight